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To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).
This trial was a 12 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Sixty patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.
Primary outcome measures were WOMAC at week 12.
Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and ESR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM OA1 | Active Comparator | JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day |
|
| Placebo | Placebo Comparator | Placebo 3 TABLET For 2 Times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JING CEIH SHERN YUAN EXTRACT PILL | Drug | Oral use, 3#BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities (WOMAC) | The investigators use WOMAC to compared the difference between the week 12 and week 0 | week 0, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| serum osteocalcin level | The investigators use serum osteocalcin level to compared the difference between week 12 and week 0 | week 0, week 12 |
| serum C-terminal telopeptide (CTX) level | The investigators use serum CTX level to compared the difference between week 12 and week 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng Ching Wei, Ph. D. | Chung Shan Medical University | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2019 | |
| Reset | Dec 5, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2019 | Dec 5, 2019 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| week 0, week 12 |
| Western Ontario and McMaster Universities (WOMAC) | The investigators use WOMAC to compared the difference between the week 4 and week 0, week 8 and week 0 | week 0, week 4, week 8 |
| Visual Analog Scale for pain (VAS) | The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0 | week 0, week 4, week 8, week 12 |
| Physicians Global Assessment to measure quality of life (PGA) | The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0 | week 0, week 4, week 8, week 12 |
| Quality of life by SF-36 | The investigators use SF-36 to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0 | week 0, week 4, week 8, week 12 |
| High sensitivity C-reactive protein (Hs-CRP) | The investigators use Hs-CRP to compared the difference between the week 12 and week 0 | week 0, week 12 |
| Erythrocyte sedimentation rate (ESR) | The investigators use ESR to compared the difference between the week 12 and week 0 | week 0, week 12 |